Morbid ObesityRQNCT01396460
Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
An observational study of Morbid Obesity, run by Gastrocirurgia, Brazil at 1 site in Brazil.
Trial summary
Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- breakfast (a chicken sandwich with juice)
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Jul 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Bariatric post operative population
Who may be able to join
- With more than 1 year after surgery
- Consent given to participate
Who cannot join
- Pregnant women
- Malnourished patients (anemia)
- Tiroid disorders without treatment
Trial locations and contacts
1 site in 1 country.
About this study
Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period.
Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients.
The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.
- Conditions
- Morbid Obesity
- Being tested
- breakfast (a chicken sandwich with juice)
- Keywords
- respiratory quotient, fat oxidation, morbid obesity, bariatric, Bariatric Surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breakfast (a chicken sandwich with juice)Other
patients received a breakfast after de initial measurement
| Study group | Role | What they receive |
|---|---|---|
| bariatric patients | Bariatric post operative patients were compared with morbid obese population Receives: Other: breakfast (a chicken sandwich with juice) | |
| control group | morbid obese population |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Induced Thermogenesis
To examine the possible changes in the thermic effect of food, the patients received a standard meal. They then repeated the test 20 minutes after eating to obtain a reading of the metabolic rate by considering the DIT and RQ in the postprandial period. DIT was calculated as the difference between post prandial metabolic rate and RMR.
Measured: 20min after standard meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gastrocirurgia, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Leite Faria, Gastrocirurgia, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396460
- Sponsor's protocol ID
- NCT01231087
- Acronym
- RQ
- Status last verified
- Sep 2012
- First submitted
- 15 Jul 2011
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients
- ClinicalTrials.gov ID
- NCT01396460
- Acronym / sponsor ID
- RQ / NCT01231087
- Conditions
- Morbid Obesity
- Keywords
- respiratory quotient, fat oxidation, morbid obesity, bariatric, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Gastrocirurgia, BrazilUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period.
Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients.
The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bariatric patients | – | Other: breakfast (a chicken sandwich with juice)Bariatric post operative patients were compared with morbid obese population |
| control group | – | –morbid obese population |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Bariatric post operative population
Key inclusion criteria (2 listed)
- With more than 1 year after surgery
- Consent given to participate
Key exclusion criteria (3 listed)
- Pregnant women
- Malnourished patients (anemia)
- Tiroid disorders without treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breakfast (a chicken sandwich with juice)patients received a breakfast after de initial measurement | Other | bariatric patients |
Primary outcome
Diet Induced Thermogenesis
Time frame: 20min after standard meal
To examine the possible changes in the thermic effect of food, the patients received a standard meal. They then repeated the test 20 minutes after eating to obtain a reading of the metabolic rate by considering the DIT and RQ in the postprandial period. DIT was calculated as the difference between post prandial metabolic rate and RMR.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by Gastrocirurgia, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Induced Thermogenesis (time frame: 20min after standard meal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2012.